Xifyrm FDA Approval History

Last updated by Judith Stewart, BPharm on June 10, 2025.

FDA Approved: Yes (First approved June 5, 2025)
Brand name: Xifyrm
Generic name: meloxicam
Dosage form: Injection
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Pain

Xifyrm (meloxicam) is a non-steroidal anti-inflammatory drug (NSAID) for use in the management of moderate-to-severe pain.

• Xifyrm is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.
  Limitation of Use: Because of delayed onset of analgesia, Xifyrm alone is not recommended for use when rapid onset of analgesia is required.
• Xifyrm contains meloxicam, an NSAID first approved in an oral tablet formulation under the brand name Mobic in 2000. It has since been approved in injectable and multiple other oral formulations.
• Meloxicam has analgesic, anti-inflammatory, and antipyretic properties. Like other NSAIDs, meloxicam is thought to work though the inhibition of cyclooxygenase (COX-1 and COX-2).
• Xifyrm is administered by intravenous bolus injection over 15 seconds, once daily. If the response is inadequate, a short-acting, non-NSAID, immediate-release analgesic can also be administered.
• The Xifyrm product label carries a Boxed Warning for an increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke), and serious gastrointestinal (GI) adverse events (including bleeding, ulceration, and perforation of the stomach or intestines). Warnings and precautions associated with Xifyrm include hepatotoxicity; impaired response to certain antihypertensive medications; worsening heart failure in patients with severe heart failure; worsening renal function patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia; anaphylactic reactions; exacerbation of asthma related to aspirin sensitivity; serious skin reactions; hematologic toxicity; and fetal toxicity.
• Common adverse reactions (≥ 2% and greater than placebo) in controlled clinical trials included constipation, increased GGT, and anemia.

Development timeline for Xifyrm

Further information

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